Date of publication: 30 December 2025
Alina Borovets, Attorney at Law
Source: Mind.ua
The past year was marked by unprecedented attention from the Antimonopoly Committee of Ukraine to the entire pharmaceutical supply chain – from manufacturers to pharmacy chains. In October 2025, the AMCU launched a large-scale case against 155 business entities that are part of the five largest pharmacy chains in Ukraine (controlling 64% of retail sales of medicines and uniting more than 7,700 pharmacies). The investigation focused on signs of possible concerted behaviour that could have led to a reduction in the range and sales of products from three Ukrainian manufacturers, assuming demand remained unchanged.
Also, this year, the committee made an unprecedented decision regarding the distributors BaDM and Optima-Farm, imposing a fine of approximately UAH 4.8 billion on them for simultaneously setting identical and/or similar sales prices for several medicines.
The increased attention from the AMCU, essentially a new approach to transparency control in the pharmaceutical market, requires its participants to carefully analyse risks and develop new standards for their own policies, document flow, and business processes. Practical advice on current compliance requirements for manufacturers, importers, and distributors of medicines in Ukraine was provided to Mind by Alina Borovets, an Attorney at Law at Ilyashev & Partners Law Firm.
New AMCU Criteria for Selecting Counterparties in the Pharmaceutical Market
Given the increased attention of the Antimonopoly Committee, contractual relations between manufacturers, importers, and distributors form the foundation of a company’s compliance system, the quality and content of which determines the ability to prove the legitimacy of economic decisions in the event of AMCU inspections.
It is important to distinguish between the classic criteria for selecting distributors, which are traditionally used in the pharmaceutical market, and the conditions that have become the subject of new attention from the AMCU.
The Established Criteria for Manufacturers and Importers Include:
- Compliance with legal requirements and the business reputation of the counterparty. This refers to the availability of all necessary founding documents, permits, and licences, the absence of criminal proceedings, and other factors that may indicate risks of improper conduct in the market.
- Financial reliability and payment discipline. Manufacturers assess the financial stability of potential partners, their ability to fulfil contractual obligations, the absence of overdue debts, and consistency in payments.
- Material and technical infrastructure. This refers to the availability of modern warehouses, distribution centres and logistics capabilities that ensure effective territorial coverage.
- Compliance with industry standards and quality requirements. The counterparty must comply with GDP and GSP standards and ensure quality control of medicinal products at all stages of the supply chain.
This year, the AMCU has recorded the practice of certain manufacturers and importers imposing additional requirements that not all potential counterparties can meet. The Committee identified these as posing risks of anti-competitive narrowing of the circle of distributors, namely:
- a certain number of supplier warehouses and their location and the number of points of sale;
- maximum delivery time for orders from the distributor to retail outlets;
- sales volume of goods on the Ukrainian market not less than the established amount;
- the period of time during which the distributor operates in Ukraine;
- the minimum order volume of the supplier and the frequency of purchases;
- the existence of a certain number of contracts with pharmaceutical companies or their representatives.
Although they may be based on the economic logic of the manufacturer (ensuring stable supplies, covering the territory or protecting the brand’s reputation), the disproportionate or excessive nature of these requirements creates risks of anti-competitive narrowing of the circle of potential partners.
The AMCU explicitly states that if the established criteria effectively narrow competition to one or several distributors, this may lead to a situation where advantages are gained not through efficiency, service quality or pricing policy, but solely through the manufacturer’s chosen mechanism of ‘advantageous differentiation,’ which is contrary to the law.
Tip: It is important for manufacturers and importers to avoid excessive conditions that go beyond real economic needs (conditions regarding the number of retail outlets, warehouses, sales volumes or the existence of contracts with large pharmaceutical companies). Such criteria create risks of discrimination and may be classified by the AMCU as barriers to market access.
Practice confirms that legally correct cooperation criteria and transparent discount mechanisms are formed not only on the basis of competition law requirements, but also through a well-designed commercial policy. A well-structured commercial policy not only reduces antitrust risks, but also becomes a key element of compliance, allowing the company to confidently justify its decisions to the AMCU.
Restrictions on the Volume of Product Supplies to a Single Counterparty
In 2025, a new model for regulating the structure of drug supplies was introduced because ill-considered cooperation criteria can artificially restrict competition, and the concentration of significant sales volumes on a single distributor creates the risk of de facto dominance in distribution channels.
The new regulation sets a limit on sales to a single distributor of no more than 20% of the previous year’s net income for each specific medicinal product. The aim is to prevent the monopolisation of distribution channels and to create equal conditions of access to goods for all distributors.
At the same time, there is an important exception: if individual distributors are unable to meet the declared demand or do not exhaust the volume set for them, the manufacturer has the right to increase supplies to another partner who demonstrates stable demand and solvency. This exception is critical for the uninterrupted supply of medicines to the population and the prevention of artificial shortages.
In such conditions, a pharmaceutical company’s compliance system must not only formally exist, but also be integrated into all supply and sales processes.
How Should Businesses Respond to the New Requirements for the Supply of Pharmaceutical Products?
Manufacturers and importers are required to implement internal control mechanisms for sales volumes to each distributor, keep records of supplies, develop procedures for when the 20% limit is approached, and ensure that every commercial decision is documented.
Justify any changes in pricing, from wholesale prices to the structure of discounts and bonuses.
Unjustified or non-transparent discounts may be classified as a tool for excluding competitors from the market or as a hidden form of coordination.
Distributors must adapt their purchasing strategies to take into account the 20% limit, ensure demand predictability, and document the need to increase purchase volumes.
Pharmacy chains should avoid any actions that could be construed as concerted practices regarding product range or simultaneous changes in purchasing conditions. Even the simultaneous removal of certain drugs from the shelves of several chains could be grounds for investigation.
The Impact of “Price” Reform on Compliance Requirements for the Pharmaceutical Market
The introduction of maximum mark-ups, reference pricing and the National Price Catalogue has shaped a new model for the pharmaceutical market, in which the pricing process has become more structured and dependent on the clear internal compliance architecture of each company. It is the level of sophistication of the compliance system that determines the ability of a business to correctly implement new pricing requirements and justify its decisions.
The essence of the reform: The National Price Catalogue forms a single source of reliable declared prices from manufacturers and importers, which becomes the starting point for the entire supply chain. Its functioning creates a certain level of transparency, where the market receives a fixed starting price.
The maximum supply and distribution mark-up of 8% has become one of the key elements of the new model. It significantly reduces the scope for individualised pricing conditions between the manufacturer and the distributor, which previously could include a wide range of discounts, bonuses and preferences.
The introduction of new trade (retail) margins for pharmacies has also transformed the interaction between market participants. With limited margins, pharmacies lose the ability to adjust the final price outside the established framework.
The reference pricing system should be viewed as a strategic element aimed at ensuring economically justified prices for medicines on the Ukrainian market. Setting a base price through cost analysis in a specific group of reference countries narrows the possibility of unjustified price increases and makes any changes in wholesale prices legally sensitive.
In legal terms, the new system creates additional opportunities for the AMCU to compare the behaviour of networks and identify potential signs of coordination.
Tip: In such conditions, control over the validity of cooperation terms, transparency of pricing decisions and documentation of commercial activities becomes not only a legal requirement, but also a key element of competitive strategy. This fundamentally changes not only contractual practice, but also the internal compliance structure of companies: all decisions must be documented, logical, and synchronised with the information entered in the catalogue.
Instead of a Conclusion
The new regulatory model for the pharmaceutical market is a system in which every economic decision must be justified, documented and consistent with the requirements of competition law.
Strengthened control by the AMCU, the introduction of supply limits, standardisation of pricing mechanisms and increased requirements for transparency in interactions between manufacturers, importers, distributors and pharmacy chains are turning compliance from a recommendation into a mandatory element of the business model.
